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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a medical device defect with no reported illnesses or injuries. The manufacturing defect (incorrect tip curve shape) presents a risk of harm to patients during cardiac catheterization procedures, warranting a High severity classification.
Plain-English summary
Guider Softip Guide Catheter 8F 90CM (Catalog number H965100480), manufactured by Boston Scientific Corporation, has been recalled due to a manufacturing defect. The affected catheters were manufactured with an incorrect tip curve shape that differs from the labeled specifications.
Approximately 17,436 units of the recalled catheters were distributed in Indiana. The defect affects the physical shape of the catheter tip, which could impact its performance and safety when used in cardiac procedures.
Healthcare providers and patients in possession of affected lots should immediately cease use of these catheters. Consumers should contact Boston Scientific Corporation to arrange for return or replacement of the affected units. A complete list of affected lot numbers is available from the FDA.
The recalled product
- Product
- Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 17,436
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 08714729202523
- Lot/Batch Numbers: 25651745
- 25651749
- 25651755
- 25761258
- 25914835
- 25915125
- 25964541
- 26138808
- 26138818
- 26138819
- 26338718
- 26339260
- 26339261
- 26498387
- 26726579
- 26726621
- 26726622
- 26726624
- 26746104
Distribution
Part of a larger recall action
This product is one of 16 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 16 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
Same hazard · device defect
See all →- SevereBard Access Systems Recalls Power-Trialysis Dialysis Catheters
FDA (Devices) · 2026-09-23
- SevereBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- HighMicrovention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects
FDA (Devices) · 2026-08-19
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22
Similar recalls
- HighBoston Scientific Guide Catheter Distributed With Wrong Tip Curve
FDA (Devices) · 2022-08-31
- ModerateStryker Neurovascular Recalls Guider Softip XF Guide Catheters
FDA (Devices) · 2016-11-09
- HighStryker Recalls Guider Guide Catheters Due to Manufacturing Defect
FDA (Devices) · 2016-11-09
- HighStryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks
FDA (Devices) · 2016-11-09
- HighCook Inc. Recalls Angled Tip Ureteral Catheter Sets Due to Loading Defect
FDA (Devices) · 2020-02-12
- ModerateStryker Neurovascular Recalls Guider Guide Catheters Due to Hub Leaks
FDA (Devices) · 2016-11-09