Boston Scientific Recalls Mislabelled Stingray Guidewires for Coronary Procedures
Boston Scientific is recalling 49 Stingray Guidewires that are 185cm but incorrectly labeled as 300cm. The mislabeling could lead to improper use during angioplasty 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: The recall involves a medical device with a labeling error that could lead to improper use during invasive procedures. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling 49 units of Stingray Guidewires. These devices are intended to facilitate the placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The specific units involved are labeled as 300cm but are actually 185cm in length.
The recall was initiated because the incorrect labeling could result in the use of a shorter guidewire than intended during medical procedures. This discrepancy in length may affect the safety and efficacy of the intervention. The affected units have the Material Number (UPN) H749M3004A0, Batch Number 21558994, and an expiration date of 11/30/2019.
The devices were distributed nationwide to facilities in Arkansas, Connecticut, Florida, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, North Dakota, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Wisconsin, and Wyoming. Healthcare facilities should stop using the affected guidewires and contact Boston Scientific for instructions on return or replacement.
The recalled product
- Product
- Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 49
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 (3)
- Material Number (UPN) H749M3004A0
- Batch Number 21558994
- Expiration Date 11/30/2019
Distribution
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