D*Clot® HD Rotational Thrombectomy System Recalled for Sterility Barrier Defect
Mermaid Medical is recalling 190 D*Clot® HD Rotational Thrombectomy Systems worldwide due to failed sterility testing that indicates the sterility barrier may not be fully intact.
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 is an FDA Class II recall of a sterile medical device with a potentially compromised sterility barrier. Although the hazard could lead to infection, no illnesses or injuries related to the devices are reported in the recall notice.
Plain-English summary
Mermaid Medical A/S is recalling 190 D*Clot® HD Rotational Thrombectomy Systems distributed worldwide. In the United States, the devices were distributed to Ohio, Missouri, Colorado, North Carolina, Texas, Massachusetts, Georgia, Florida, Illinois, Indiana, Maryland, Pennsylvania, and Virginia. The devices were also distributed to Chile.
The D*Clot® HD is a percutaneous catheter-based medical device used in vascular procedures to break up blood clots. Internal product testing revealed that the recalled devices failed bubble leak testing, a test specified by ASTM F2096 that evaluates the integrity of the device's sterility barrier. A failed bubble leak test indicates the sterility barrier may not be fully intact.
The recalled devices have lot code S2306001 and Unique Device Identifier 15711055004333. Mermaid Medical A/S initiated this recall.
The recalled product
- Product
- The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposable system consists of an outer sheath through which a rotatable radiopaque spiral shaft extends ending in an eccentric blunt distal tip. Once activated, the…
- Manufacturer
- Mermaid Medical A/S
- Affected units
- 190
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)
- Unique Device Identifier: 15711055004333
- Lot codes: S2306001
- Model Number: T10106065
Distribution
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