FRED Flow Re-Direction Endoluminal Device recalled for incorrect inner stent length
The FDA is recalling FRED Flow Re-Direction Endoluminal Devices due to a manufacturing defect that may result in incorrect inner stent length, potentially affecting device performance. 474 units were affected.
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 a Class II FDA recall affecting a critical medical device (intracranial aneurysm treatment) with a manufacturing defect that could prevent proper device function. No injuries or illnesses have been reported. Per the rubric, this qualifies as High (3) — a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The FDA has issued a Class II recall of the FRED Flow Re-Direction Endoluminal Device, manufactured by MICROVENTION INC. This device is used to treat intracranial aneurysms. The recall affects 474 units that were manufactured between June 1, 2020, and September 29, 2020.
The devices may have been manufactured with an incorrect inner stent length, which could prevent the device from performing as intended. No injuries or illnesses have been reported to date.
The affected devices were distributed worldwide, including to healthcare facilities across the United States and in multiple countries internationally.
Patients and healthcare providers who have used or may use these devices should contact their healthcare provider immediately. For additional information regarding the recall, healthcare facilities should contact MICROVENTION INC. or the FDA.
The recalled product
- Product
- FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, FRED3524-PMA, FRED3536-CA, FRED3536-PMA, FRED4007-PMA, FRED4012-CA, FRED4012-PMA, FRED4017-PMA, FRED4026, FRED4026-PMA, FRED4038-PMA, FRED4508…
- Manufacturer
- MICROVENTION INC.
- Affected units
- 474
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 (20)
- Devices manufactured between June 1
- 2020
- and September 29
- 2020. REF/UDI/Lot: FRED3507-PMA/00842429106655/200703556
- 20070654P
- 20072255L
- 20072255N
- 20073056A
- 20073056B
- 200807599
- 20081453X
- 20082656F
- 20082656G
- 20082852H
- 20083152E
- FRED3511/20073054C
- 20091654Z
- 200917511
- FRED3511-PMA/00842429106662/20070754K
- 200716562
Distribution
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