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.
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 medical device with a functional defect (incorrect tip curve shape that differs from labeled specification). No illnesses, injuries, or adverse events have been reported. Per the severity rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' corresponding to a High severity score.
Plain-English summary
Boston Scientific Corporation is recalling certain lots of its Guider Softip Guide Catheter 6F PRE-SHAPED (Catalog number H965100420). The recall involves 4,990 units of this cardiac guide catheter.
The recalled products have an incorrect tip curve shape that differs from the labeled specification.
According to available distribution data, the affected products were distributed nationwide in the state of Indiana. The recall includes 64 specific lot numbers.
Healthcare providers and patients with the recalled products should contact Boston Scientific for return or replacement instructions. Patients who received this device should consult their healthcare provider.
The recalled product
- Product
- Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 4,990
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 08714729202462
- Lot/Batch Numbers: 25651700
- 25651701
- 25651702
- 25651703
- 25651704
- 25651705
- 25651706
- 25651708
- 25651709
- 25651710
- 25651711
- 25761340
- 25761341
- 25761342
- 25761343
- 25964544
- 25964545
- 25964546
- 25964547
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.
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