Medtronic Durepair Dura Matrix Recalled Due to Endotoxin Contamination
Medtronic is recalling Durepair Dura Regeneration Matrix surgical implants worldwide due to potential endotoxin contamination that may cause inflammation similar to infection.
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: FDA Class II medical device recall with a serious potential hazard—endotoxin contamination that may trigger inflammatory response comparable to infection. However, the source text does not report any illnesses or injuries, and the hazard is theoretical. Per the rubric, a score is at most 3 when illnesses are not reported and the hazard is theoretical.
Plain-English summary
Medtronic Neurosurgery is recalling Durepair Dura Regeneration Matrix surgical implants in multiple sizes. Approximately 65,029 units have been distributed worldwide across all U.S. states and numerous other countries.
The implants may contain out-of-specification endotoxin levels due to problems with in-process and finished goods testing procedures. Endotoxin can cause signs and symptoms of an acute inflammatory process comparable to infection.
The recall affects implants manufactured with various lot numbers, with expiration dates extending to May 2025. Anyone who has received these implants should contact their healthcare provider with questions about the recall and their individual situation.
The recalled product
- Product
- Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE…
- Manufacturer
- Medtronic Neurosurgery
- Affected units
- 65,029
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)
- REF/Expiration Date On or Prior/UDI-DI/Lots: 61100/March 31
- 2025/00643169063808/2006039
- 2007020
- 2009028
- 2010001
- 2010016
- 2102001
- 2102020
- 2103001
- 2105028
- 2106001
- 2108011
- 2108017
- 2109022
- 2110009
- 2110030
- 2111023
- 2111045
- 2112026
- 2203020
Distribution
Related recalls
Same manufacturer · Medtronic Neurosurgery
See all →- HighMedtronic Neurosurgery Recalls Ventriculostomy Kit Due to High Endotoxin Levels
FDA (Devices) · 2026-07-29
- SevereExacta External Drainage System Stopcocks May Leak or Crack
FDA (Devices) · 2024-12-25
- SevereMedtronic Becker Neurosurgical Drainage Systems Recalled for Cracked and Leaking Stopcocks
FDA (Devices) · 2024-12-25
- SevereMedtronic Duet Catheter System Recalled for Potential Disconnection Risk
FDA (Devices) · 2024-03-06
- SevereMedtronic Duet Ventricular Catheter Recalled for Disconnection Risk
FDA (Devices) · 2024-03-06
Same hazard · endotoxin
See all →- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Neurological Sponges Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
- SevereMedline Neurological Sponges Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Craniotomy Kits Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
Similar recalls
- HighDural Graft Implants Recalled for Out-of-Specification Endotoxin Levels
FDA (Devices) · 2024-11-06
- HighRESODURA Matrix Onlay Recalled Due to Unsealed Packaging
FDA (Devices) · 2022-03-02
- HighMedtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels
FDA (Devices) · 2013-07-03
- HighIntegra Recalls Surgical Patties and Strips Due to Endotoxin Levels
FDA (Devices) · 2024-11-06
- HighMedtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Concerns
FDA (Devices) · 2013-07-03
- SevereMedtronic Implantable Insulin Pump Recalled for Endotoxin Contamination
FDA (Devices) · 2020-06-10