Apollo Onyx Delivery Microcatheter recalled for incorrect indications for use
Micro Therapeutics is recalling Apollo Onyx Delivery Microcatheter devices with incorrect indications for use. European-version devices were distributed in the U.S. across 29 states.
What this means for you
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 a Class II medical device recall involving labeling with incorrect indications for use. Although no illnesses or injuries have been reported, the mislabeled device poses a potential risk of harm through inappropriate clinical use.
Plain-English summary
Micro Therapeutics is recalling Apollo Onyx Delivery Microcatheter devices with incorrect indications for use. Ninety-five units were distributed nationwide across 29 states. The affected lot numbers are B510758, B555761, B615024, B615025, B629693, and B629694.
These recalled devices are European versions of the product that contain indications for use different from those approved for the U.S. market. The labeling instructions on the recalled devices do not match the regulatory requirements for distribution and use in the United States.
Healthcare facilities and medical centers in the affected states may have received these devices. Inventory should be checked against the recalled lot numbers.
The recalled product
- Product
- The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of
- Manufacturer
- Micro Therapeutics, Inc.
- Category
- Medical Device — Microcatheter
- Hazard
- Affected units
- 95
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 (6)
- UDI: 00763000311445/ Lot # B510758
- B555761
- B615024
- B615025
- B629693
- B629694
Distribution
Part of a larger recall action
This product is one of 2 recalled by Micro Therapeutics, Inc. 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.
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