The Recall Desk

Manufacturer

Boston Scientific Corp

7 recalls in our database name Boston Scientific Corp as the manufacturing or recalling firm.

What the numbers show

Total
7
Critical
0
Severe
1
Most recent
2015-12-30

Of the 7 recalls from Boston Scientific Corp we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (14%) 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.

1–7 of 7

  • HighFDA (Devices)·Z-0463-2016·2015-12-30

    Boston Scientific Recalls IntellaTip MiFi XP Catheters Due to Tip Bends

    Boston Scientific is recalling IntellaTip MiFi XP catheters because the rate of distal tip bends and kinks exceeded anticipated levels during routine monitoring.

    Product
    IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 OUS; Material Number: M004EPM4790N40; Catalog number: EPM4790N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0465-2016·2015-12-30

    Boston Scientific Recalls IntellaTip MiFi XP Catheters Due to Tip Bends

    Boston Scientific is recalling IntellaTip MiFi XP catheters because the rate of distal tip bends and kinks exceeded anticipated levels during routine monitoring.

    Product
    IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 ; Material Number: M004PM4790N40; Catalog number: PM4790N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for tr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0464-2016·2015-12-30

    Boston Scientific Recalls IntellaTip MiFi XP Catheters Due to Tip Bends

    Boston Scientific is recalling IntellaTip MiFi XP catheters because the rate of distal tip bends and kinks exceeded anticipated levels during routine monitoring.

    Product
    IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M004PM4500N40; Catalog number: PM4500N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0462-2016·2015-12-30

    Boston Scientific Recalls IntellaTip MiFi XP Catheters Due to Tip Bends

    Boston Scientific is recalling IntellaTip MiFi XP catheters because the rate of distal tip bends and kinks exceeded anticipated levels during routine monitoring.

    Product
    IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Number: M004EPM4500N40; Catalog number: EPM4500N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0402-2016·2015-12-16

    Boston Scientific Recalls One Step Button PEG Kits Due to Adapter Defect

    Boston Scientific is voluntarily recalling specific lots of One Step Button PEG kits because a protrusion on the decompression tube adapter may prevent the device from being inserted or removed.

    Product
    One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-1209-2015·2015-03-11

    Boston Scientific Recalls IntellaTip MiFi Radiofrequency Ablation Catheters

    Boston Scientific is recalling 14 IntellaTip MiFi radiofrequency ablation catheters due to reports of char formation on the distal tip electrodes.

    Product
    IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20, Catalog Number: EPM9620K2; Material number : M004EPM9620N40; Catalog number: EPM9620N4. The IntellaTip MiFi Open-Ir
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0580-2015·2014-12-17

    Boston Scientific Recalls IntellaMap Orion Mapping Catheters Due to Glue Failure

    Boston Scientific is recalling 184 IntellaMap Orion High Resolution Mapping Catheters because a glue bond on the Deployment Interlock Button may fail.

    Product
    IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64S; Is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
    Category
    Medical Device
    Distribution
    4 states

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.