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.
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 a Class II medical device with a functional defect used in invasive cardiac procedures, presenting a risk of patient harm. However, no illnesses or injuries have been reported. This falls under the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Boston Scientific is recalling Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE (Catalog number H965100470), a cardiac guide catheter used in vascular intervention procedures.
Certain units were distributed with an incorrect tip curve shape that differs from the labeled specification. This manufacturing defect may affect how the catheter performs during use in cardiac procedures.
Approximately 3,783 units have been distributed. The affected products are identified by specific lot numbers and have been distributed in the United States, with documented distribution in Indiana.
Healthcare providers and medical institutions should verify the product lot number against the recall list before using this device. Do not use affected catheters. Contact Boston Scientific for replacement or return instructions.
The recalled product
- Product
- Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 3,783
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 08714729202516
- Lot/Batch Numbers: 25761345
- 26059398
- 26138707
- 26599635
- 26599636
- 25761344
- 25964138
- 25964139
- 25964480
- 25964481
- 25964482
- 26059399
- 26130252
- 26130253
- 26138708
- 26277183
- 26599634
- 26599637
- 26746100
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
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Same hazard · incorrect shape
See all →- HighGuider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape
FDA (Devices) · 2023-10-11
- HighGuider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape
FDA (Devices) · 2023-10-11
- HighCardiac Guide Catheter Recalled Due to Incorrect Tip Curve Shape
FDA (Devices) · 2023-10-11
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