RECONIX 0114115Recalls & reported problems
Davol Inc. · Bard Reconix · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741011818), received between Nov 14, 2025 and Nov 14, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Migration1
Patient problems
- Adhesion(s)1
- Hernia1
- Scar Tissue1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2025Migration; Migration
PER INFORMATION PROVIDED: ON (B)(6) 2004 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT FLANK VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF RECONIX MESH (DEVICE 1). PER OPERATIVE NOTES, ¿MULTIPLE ADHESIONS WERE TAKEN DOWN. A RECONIX MESH (DEVICE 1) WAS PLACED AND SUTURED INTO THE DEFECT.¿ ON (B)(6) 2004 ¿ PATIENT WAS DIAGNOSED WITH RIGHT FLANK RECURRENT HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF RECONIX MESH (DEVICE 2) AND BARD FLAT MESH (DEVICE 3). PER OPERATIVE NOTES, ¿THE SCAR TISSUE WAS EXCISED. THE OLD RECONIX MESH (DEVICE 1) WAS IDENTIFIED, AND DISSECTION REVEALED A HERNIA. THE HERNIA SAC WAS DISSECTED. IN THE PERITONEAL SIDE OF THE HERNIA, A RECONIX MESH (DEVICE 2) WAS PLACED AND SUTURED. A BARD FLAT MESH (DEVICE 3) WAS PLACED AND TACKED.¿ ON (B)(6) 2006 ¿ PATIENT WAS DIAGNOSED WITH RIGHT FLANK RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESHES (DEVICE 1, 2, 3) AND AN IMPLANT OF DULEX MESH (DEVICE 4). PER OPERATIVE NOTES, ¿A SIGNIFICANT ADHESIOLYSIS OF THE RIGHT COLON THAT WAS ADHERED TO THE HERNIA SAC ITSELF. THERE WAS ANOTHER PRIOR MESH WAS SEEN THAT SEEMED TO HAVE HAD FALLEN AWAY FROM PART OF THE WALL. THE MULTI
Patient problems: Adhesion(s); Hernia; Scar Tissue
MAUDE report 23553281 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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