NAMIC 70055009 (UDI H965700550090)Recalls & reported problems
Navilyst Medical, Inc. · STOPCOCK · Class 2
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI H965700550090), received between Nov 28, 2016 and Nov 28, 2017 — classified as 17 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (17 reports).
2 other recalls cover devices cleared under the same FDA submission (K842829); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Tear, Rip or Hole in Device Packaging17
Patient problems
- Not Applicable17
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 28, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), IN THE DISTRIBUTOR'S WAREHOUSE A SMALL HOLE WAS FOUND IN THE TYVEK PORTION OF A STOPCOCK POUCH, BREACHING THE STERILITY. THE DEVICE HAD NOT BEEN PROVIDED TO A HOSPITAL AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 7064386 ↗MalfunctionNov 28, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), IN THE DISTRIBUTOR'S WAREHOUSE A SMALL HOLE WAS FOUND IN THE TYVEK PORTION OF A STOPCOCK POUCH, BREACHING THE STERILITY. THE DEVICE HAD NOT BEEN PROVIDED TO A HOSPITAL AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 7064379 ↗MalfunctionJan 20, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6), IN THE DISTRIBUTOR'S WAREHOUSE A SMALL HOLE WAS FOUND IN THE TYVEK PORTION OF A STOPCOCK POUCH, BREACHING THE STERILITY. THE DEVICE HAD NOT BEEN PROVIDED TO A HOSPITAL, AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 6267731 ↗MalfunctionDec 2, 2016Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6), IN THE DISTRIBUTOR'S WAREHOUSE A SMALL HOLE WAS FOUND IN THE TYVEK PORTION OF A STOPCOCK POUCH, BREACHING THE STERILITY. THE DEVICE HAD NOT BEEN PROVIDED TO A HOSPITAL, AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 6142799 ↗MalfunctionDec 2, 2016Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), IN THE DISTRIBUTOR'S WAREHOUSE A SMALL HOLE WAS FOUND IN THE TYVEK PORTION OF A STOPCOCK POUCH, BREACHING THE STERILITY. THE DEVICE HAD NOT BEEN PROVIDED TO A HOSPITAL, AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 6142790 ↗MalfunctionDec 2, 2016Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4) , IN THE DISTRIBUTOR'S WAREHOUSE A SMALL HOLE WAS FOUND IN THE TYVEK PORTION OF A STOPCOCK POUCH, BREACHING THE STERILITY. THE DEVICE HAD NOT BEEN PROVIDED TO A HOSPITAL, AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 6142774 ↗MalfunctionDec 2, 2016Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), IN THE DISTRIBUTOR'S WAREHOUSE A SMALL HOLE WAS FOUND IN THE TYVEK PORTION OF A STOPCOCK POUCH, BREACHING THE STERILITY. THE DEVICE HAD NOT BEEN PROVIDED TO A HOSPITAL, AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 6142767 ↗MalfunctionDec 2, 2016Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6), IN THE DISTRIBUTOR'S WAREHOUSE A SMALL HOLE WAS FOUND IN THE TYVEK PORTION OF A STOPCOCK POUCH, BREACHING THE STERILITY. THE DEVICE HAD NOT BEEN PROVIDED TO A HOSPITAL, AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 6142761 ↗MalfunctionDec 2, 2016Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED BY ANGIODYNAMICS' (B)(4), IN THE DISTRIBUTOR'S WAREHOUSE A SMALL HOLE WAS FOUND IN THE TYVEK PORTION OF A STOPCOCK POUCH, BREACHING THE STERILITY. THE DEVICE HAD NOT BEEN PROVIDED TO A HOSPITAL, AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 6142742 ↗MalfunctionDec 2, 2016Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED BY (B)(4), IN THE DISTRIBUTOR'S WAREHOUSE A SMALL HOLE WAS FOUND IN THE (B)(6) PORTION OF A STOPCOCK POUCH, BREACHING THE STERILITY. THE DEVICE HAD NOT BEEN PROVIDED TO A HOSPITAL, AND WAS RETURNED TO (B)(4) FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 6142723 ↗MalfunctionNov 28, 2016Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), IN THE DISTRIBUTOR'S WAREHOUSE, A SMALL HOLE WAS FOUND IN THE TYVEK PORTION OF A STOPCOCK POUCH, BREACHING THE STERILITY. THE DEVICE HAD NOT BEEN PROVIDED TO A HOSPITAL, AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 6128471 ↗MalfunctionNov 28, 2016Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), IN THE DISTRIBUTOR'S WAREHOUSE A SMALL HOLE WAS FOUND IN THE TYVEK PORTION OF A STOPCOCK POUCH, BREACHING THE STERILITY. THE DEVICE HAD NOT BEEN PROVIDED TO A HOSPITAL, AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 6128470 ↗MalfunctionNov 28, 2016Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), IN THE DISTRIBUTOR'S WAREHOUSE A SMALL HOLE WAS FOUND IN THE TYVEK PORTION OF A STOPCOCK POUCH, BREACHING THE STERILITY. THE DEVICE HAD NOT BEEN PROVIDED TO A HOSPITAL, AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 6128468 ↗MalfunctionNov 28, 2016Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), IN THE DISTRIBUTOR'S WAREHOUSE A SMALL HOLE WAS FOUND IN THE TYVEK PORTION OF A STOPCOCK POUCH, BREACHING THE STERILITY. THE DEVICE HAD NOT BEEN PROVIDED TO A HOSPITAL, AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 6128467 ↗MalfunctionNov 28, 2016Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), IN THE DISTRIBUTOR'S WAREHOUSE A SMALL HOLE WAS FOUND IN THE TYVEK PORTION OF A STOPCOCK POUCH, BREACHING THE STERILITY. THE DEVICE HAD NOT BEEN PROVIDED TO A HOSPITAL, AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 6128465 ↗MalfunctionNov 28, 2016Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), IN THE DISTRIBUTOR'S WAREHOUSE A SMALL HOLE WAS FOUND IN THE TYVEK PORTION OF A STOPCOCK POUCH, BREACHING THE STERILITY. THE DEVICE HAD NOT BEEN PROVIDED TO A HOSPITAL, AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 6128460 ↗MalfunctionNov 28, 2016Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4) , IN THE DISTRIBUTOR'S WAREHOUSE A SMALL HOLE WAS FOUND IN THE TYVEK PORTION OF A STOPCOCK POUCH, BREACHING THE STERILITY. THE DEVICE HAD NOT BEEN PROVIDED TO A HOSPITAL, AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 6128459 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K842829. One submission often covers many models, so check the product and lot details in each record.
- Z-2574-2021 · Aug 6, 2021 · TerminatedNAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifold, Off Star Handles, Ports on Right, Rx only, Sterile; (
- Z-2575-2021 · Aug 6, 2021 · TerminatedNAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only, Sterile; (2) NAMIC STOPCOCK, 200 psi
Other Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass devices
- Indeflator 1003327Abbott Vascular Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass2 recalls722 reports
- Copilot 1003331Abbott Vascular Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass189 reports
- DLP® 11001GMedtronic, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass2 recalls0 reports
- RHV 23242Abbott Vascular Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass66 reports
- DLP® 14000Medtronic, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall2 reports
- PhD™ 00884450746745Merit Medical Systems, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall2 reports
- PhD™ 00884450746714Merit Medical Systems, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall1 report
- NAMIC 64038301Medline Industries, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.