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.
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: FDA Class II device with a manufacturing defect affecting a cardiac catheter's geometry. No illnesses or injuries have been reported. This meets the High-severity criterion as a risk-of-harm medical device where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling 1,728 units of the Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM (Catalog number M003101420) due to a manufacturing defect. Certain lots of this cardiac guide catheter were distributed with a tip curve shape that differs from the labeled tip curve shape specification.
The recalled product was distributed nationwide in the state of Indiana. The affected lot numbers are: 26138711, 26276489, 26276490, 26590803, 26746110, 26891804, 26891805, 27162093, 27162094, 27203536, 27431372, 26059693, 26138710, 26276491, 26590802, 26746111, 27203537, 27219436, 27431373, 27526941, 27801040, 28811942, 28811943.
Healthcare facilities should immediately discontinue use of the affected product lots. Contact Boston Scientific Corporation for guidance on inspection, replacement, or return of recalled units.
The recalled product
- Product
- Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 1,728
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 08714729244295
- Lot/Batch Numbers: 26138711
- 26276489
- 26276490
- 26590803
- 26746110
- 26891804
- 26891805
- 27162093
- 27162094
- 27203536
- 27431372
- 26059693
- 26138710
- 26276491
- 26590802
- 26746111
- 27203537
- 27219436
- 27431373
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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