Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape
Boston Scientific is recalling certain lots of Guider Softip Guide Catheters due to an incorrect tip curve shape. The affected devices were distributed with a different tip curve than labeled.
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 FDA Class II recall involves a cardiac guide catheter with incorrect tip curve shape compared to labeled specifications. No illnesses or injuries are reported in the source material. Per the rubric, risk-of-harm medical devices without reported injury receive a High severity rating.
Plain-English summary
Boston Scientific Corporation is recalling certain lots of the Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE (Catalog number M003101480). The recalled devices are cardiac guide catheters that were distributed with an incorrect tip curve shape.
The 3,777 affected units have a tip curve shape that differs from the labeled tip curve shape. This deviation was identified after distribution.
The affected devices were distributed nationwide in Indiana. Multiple lot numbers are affected, including 26277188, 26599713, 26709826, 27170547, 27203658, 27339851, 27535146, 27728492, 27902047, 28320867, 28564218, 28616007, 28632345, 26138706, 26277189, 26411756, 26411757, 26599714, 26599715, 26709827, 26746119, 26746120, 26891840, 26891841, 26984254, 27254933, 27379026, 27379027, 27558597, 27645561, 27782880, 27980980, 27988374, 28320864, 28320865, 28320866, 28564219, 28564380, 28584613, 28616008, 28632340, 28632341, 28632342, and 29513117.
Healthcare providers with these devices should check lot numbers against the recall list. Contact Boston Scientific for replacement devices or further information.
The recalled product
- Product
- Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 3,777
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 08714729244356
- Lot/Batch Numbers: 26277188
- 26599713
- 26709826
- 27170547
- 27203658
- 27339851
- 27535146
- 27728492
- 27902047
- 28320867
- 28564218
- 28616007
- 28632345
- 26138706
- 26277189
- 26411756
- 26411757
- 26599714
- 26599715
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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