The Recall Desk

Manufacturer

Boston Scientific Corporation

639 recalls in our database name Boston Scientific Corporation as the manufacturing or recalling firm.

What the numbers show

Total
639
Critical
57
Severe
102
Most recent
2026-09-09

Of the 639 recalls from Boston Scientific Corporation we have scored against our rubric, 57 (9%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 102 (16%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

251–275 of 639

  • HighFDA (Devices)·Z-1517-2024·2024-04-17

    EndoVive 20 Fr Feeding Tube May Obstruct During Placement

    Boston Scientific is recalling EndoVive 20 Fr feeding tubes due to potential blockage during placement that may prevent guidewire advancement. This could lead to procedure complications including bleeding, gastric leakage, or aspiration.

    Product
    EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00509191
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1513-2024·2024-04-17

    EndoVive 20Fr Push Safety PEG Kit Recall Due to Blocked Lumen Risk

    Boston Scientific is recalling the EndoVive 20Fr PEG feeding kit due to blockage in the barb connector that can prevent proper placement. The blockage may lead to prolonged procedures, bleeding, gastric leakage, and aspiration risk.

    Product
    EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00509011
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1514-2024·2024-04-17

    PEG Feeding Tube Kit Recalled for Blocked Lumen Preventing Guidewire Advancement

    Boston Scientific is recalling 572 EndoVive PEG feeding tube kits due to a blocked lumen in the barb connector that may prevent guidewire advancement during placement, potentially requiring device exchange and increasing risk of complications.

    Product
    EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00509051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1516-2024·2024-04-17

    PEG feeding tube with blocked connector may impede placement procedure

    Boston Scientific's EndoVive 20Fr PEG Kit may have a blocked connector that prevents the guidewire from advancing during placement, potentially causing complications including bleeding and aspiration.

    Product
    EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00568211
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1515-2024·2024-04-17

    Feeding tube kit recalled due to blocked connector preventing guidewire advancement

    Boston Scientific's EndoVive 20Fr PEG kit may have a blocked connector preventing proper guidewire advancement during placement, potentially requiring emergency intervention.

    Product
    EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00566471
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1374-2024·2024-04-03

    Obsidio Conformable Embolic coils recalled for bowel-ischemia risk

    Boston Scientific recalled 985 Obsidio Conformable Embolic coils because using the aliquot delivery technique for lower GI bleeding poses a high risk of bowel ischemia requiring major surgery.

    Product
    Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1302-2024·2024-04-03

    Boston Scientific steerable sheath devices recalled due to manufacturing defect risk

    Boston Scientific is recalling 461 POLARSHEATH Steerable Sheath devices due to a manufacturing tooling error that may cause inner sheath delamination and potential fragment release during medical procedures.

    Product
    Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1396-2024·2024-04-03

    Certain OptiCross Coronary Imaging Catheters recalled for manufacturing defect

    Boston Scientific recalls certain batches of OptiCross Coronary Imaging Catheters manufactured with an incorrect voltage setting that may cause decreased image brightness.

    Product
    OptiCross Coronary Imaging Catheter, REF H749518080120
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1390-2024·2024-04-03

    Boston Scientific iSLEEVE Expandable Introducer Sets Recalled for Hemostatic Valve Leak

    Boston Scientific is recalling specific batches of the iSLEEVE Expandable Introducer Set due to hemostatic valve leaks affecting 4,060 devices. The devices are distributed in the US, Canada, and worldwide.

    Product
    Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1153-2024·2024-02-28

    EndoVive Replacement Button Kits mislabeled with incorrect sizing

    Boston Scientific is recalling EndoVive Replacement Button Kits due to sizing mislabeling that could cause undersizing and serious complications including tissue damage and sepsis.

    Product
    EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0673-2024·2024-01-17

    Boston Scientific ZOOM LATITUDE Pacemaker Programmer Software Displays Incorrect Diagnostic Dates

    Boston Scientific is recalling pacemaker programmer software that displays certain diagnostic dates incorrectly, with dates showing years in the 1990s. Affected diagnostic information may impact clinical monitoring.

    Product
    Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra, a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0397-2024·2023-11-29

    EXALT Model D Single-Use Duodenoscope Recalled for Lens Fluid Ingress

    Boston Scientific is recalling EXALT Model D Single-Use Duodenoscopes due to fluid ingress in the lens, which causes poor image quality during procedures.

    Product
    EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0396-2024·2023-11-29

    Boston Scientific EXALT Model D Duodenoscope Recall: Fluid Ingress in Lens

    Boston Scientific is recalling certain EXALT Model D Single-Use Duodenoscopes worldwide due to fluid ingress in the lens, which causes poor image quality. Affected devices should not be used; contact the manufacturer.

    Product
    EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0020-2024·2023-10-11

    Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape

    Boston Scientific is recalling certain lots of Guider Softip cardiac guide catheters because they were distributed with an incorrect tip curve shape that doesn't match the product label. Approximately 3,738 units were affected.

    Product
    Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0013-2024·2023-10-11

    Guider Softip Guide Catheter with Incorrect Tip Curve Shape

    Boston Scientific is recalling Guider Softip Guide Catheters due to an incorrect tip curve shape that differs from the labeled specification. The affected units may not perform as intended during cardiac procedures.

    Product
    Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0010-2024·2023-10-11

    Boston Scientific Guider Softip Guide Catheter Recalled for Incorrect Tip Shape

    Boston Scientific is recalling Guider Softip Guide Catheters from certain lots because the tip curve shape does not match the labeled specification. No illnesses or injuries have been reported.

    Product
    Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0023-2024·2023-10-11

    Guider Softip Guide Catheters recalled for incorrect tip curve shape

    Boston Scientific is recalling certain Guider Softip Guide Catheters due to incorrect tip curve shape that differs from the label. The recall affects 1170 units distributed in Indiana.

    Product
    Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0011-2024·2023-10-11

    Cardiac Guide Catheter Recalled Due to Incorrect Tip Curve Shape

    Boston Scientific recalls certain Guider Softip Guide Catheters with incorrect tip curve shapes that differ from labeled specifications. Approximately 8,475 units were distributed nationwide.

    Product
    Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0024-2024·2023-10-11

    Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape

    Guider Softip Guide Catheter (cardiac device) is being recalled because certain units have an incorrect tip curve shape that differs from the label. A total of 116 units have been distributed.

    Product
    Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0012-2024·2023-10-11

    Cardiac guide catheters recalled for incorrect tip curve

    Boston Scientific is recalling Guider Softip Guide Catheters because certain lots were distributed with an incorrect tip curve shape that differs from labeled specifications.

    Product
    Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0014-2024·2023-10-11

    Cardiac Guide Catheters Recalled for Incorrect Tip Curve Shape

    Certain lots of Guider Softip Guide Catheters were manufactured with an incorrect tip curve shape that differs from labeled specifications. The recalled devices include 17,436 units distributed in Indiana.

    Product
    Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0019-2024·2023-10-11

    Boston Scientific Guider Softip Guide Catheter Recalled for Incorrect Tip Shape

    Boston Scientific is recalling Guider Softip Guide Catheters (Catalog M003101440) in certain lots due to incorrect tip curve shape that differs from the labeled specification. The recall affects 2,184 units.

    Product
    Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0018-2024·2023-10-11

    Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape

    Boston Scientific is recalling 1004 units of Guider Softip Guide Catheters because certain lots were distributed with an incorrect tip curve shape that differs from the labeled specifications.

    Product
    Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0017-2024·2023-10-11

    Cardiac guide catheter recalled for incorrect tip curve shape

    Boston Scientific is recalling 1,728 units of Guider Softip Guide Catheter 6F due to a manufacturing defect producing incorrect tip curve shapes differing from labeled specifications.

    Product
    Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0009-2024·2023-10-11

    Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape

    Boston Scientific is recalling certain lots of Guider Softip Guide Catheters because they were manufactured with an incorrect tip curve shape that differs from the labeled specification.

    Product
    Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Boston Scientific

worldwide developer, manufacturer and marketer of medical devices

Country
United States
Founded
1979

Official website

Source: Wikidata (Q894585), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.