Boston Scientific Guider Softip Guide Catheter Recalled for Incorrect Tip Shape
Boston Scientific is recalling Guider Softip Guide Catheters (Catalog M003101440) in certain lots due to incorrect tip curve shape that differs from the labeled specification. The recall affects 2,184 units.
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 medical device recall addresses an incorrect physical defect (wrong tip curve shape) in a cardiac guide catheter. Although no illnesses or injuries have been reported, this represents a risk-of-harm product where the defect could affect device performance during cardiac procedures. Per the severity rubric, risk-of-harm products with no reported injury are classified as High.
Plain-English summary
Boston Scientific Corporation is recalling certain lots of Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM (Catalog number M003101440) due to an incorrect tip curve shape. The affected products were distributed with a tip curve shape that differs from the labeled tip curve shape.
A cardiac guide catheter with the wrong tip curve shape could affect proper device performance during cardiac procedures. The defect was observed in 29 specific lot/batch numbers: 25823581, 26059696, 26130255, 26277192, 26746112, 26984240, 27241920, 25823580, 25964485, 25964486, 25964487, 26059694, 26130254, 26277190, 26277191, 26599708, 26599709, 26599710, 26599711, 26599712, 26746113, 26984241, 26984253, 27203538, 27203539, 27379022, 28384669, 28632346, 28632344.
Approximately 2,184 units were distributed nationwide in Indiana. Healthcare providers using products from these lot numbers should take appropriate action based on guidance from Boston Scientific Corporation.
The recalled product
- Product
- Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 2,184
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 08714729244318
- Lot/Batch Numbers: 25823581
- 26059696
- 26130255
- 26277192
- 26746112
- 26984240
- 27241920
- 25823580
- 25964485
- 25964486
- 25964487
- 26059694
- 26130254
- 26277190
- 26277191
- 26599708
- 26599709
- 26599710
- 26599711
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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