Boston Scientific Recalls Opticross 35 Peripheral Imaging Catheters
Boston Scientific is recalling 41 Opticross 35 Peripheral Imaging Catheters because length markings may flake off during manipulation. No patient harm has been reported.
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 risk-of-harm medical device where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Boston Scientific Corporation is recalling 41 units of the Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm. The recall affects devices with expiration dates between June 8, 2021, and July 22, 2021, specifically lots #25754545, #25852104, #2582106, and #25856700. The devices are intended for ultrasound examination of peripheral vascular pathology.
The recall was initiated because the incremental telescoping length markings near the proximal end of the catheter shaft can flake off when the device is manipulated. The most common potential adverse health consequence is a prolonged procedure to exchange the catheter, as the issue is observable and occurs outside the patient's body. The most severe reasonably expected health consequence is embolization, which could result if flaking marks advance while flushing the catheter.
The devices were distributed nationwide in the United States, including in Maryland, New York, Michigan, Connecticut, South Dakota, and Georgia. No patient harm has been reported to date. All recalled devices should be returned to Boston Scientific.
The recalled product
- Product
- Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021 Material Number (UPN) # H7493932800350 UDI # 08714729984542 Lot #25754545; 25852104; 2582106; 25856700 Product Usage: intended for ultrasound examination of…
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 41
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)
- 25852104
- 2582106
- 25856700
Distribution
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