Boston Scientific Recalls Imager II 5F Angiographic Catheters Due to Tip Detachment Risk
Boston Scientific is recalling Imager II 5F Angiographic Catheters because the tips may detach. The recall covers 1,068,827 units distributed worldwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source metadata explicitly states the agency classification is Class I. According to the rubric, FDA Class I recalls are assigned a severity score of 5 (Critical).
Plain-English summary
Boston Scientific Corporation is recalling Imager II 5F Angiographic Catheters, 5 units per package. The recall is due to a potential for tip detachment. The affected product quantity is 1,068,827 single units.
The recall includes all lots of specific material numbers for the 5F curved tip shapes of the Imager II Angiographic Catheters. The firm expanded the recall to include all lots/batches of the 5F curved tip shapes on August 5, 2020. The products were distributed worldwide, including in the United States, Australia, and numerous other countries.
No specific instructions for consumers are provided in the source text, but the recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- Imager II 5F Angiographic Catheters, 5 units per package.
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 1,068,827
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 (1)
- All lots of the following: 1 Material Number (UPN) Outer Package M001314041
Distribution
Distributed nationwide across the United States.
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