Device, Intravascular Catheter Securement
FDA adverse event reports and recall history for device, intravascular catheter securement (product code KMK), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 744
- Deaths
- 3
- Injuries
- 81
- Malfunctions
- 639
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2017-05-19TerminatedProcess control
StatLock IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases containing 250 devices.
StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip.
- 2017-01-10TerminatedProcess design
StatLock PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per carton and 10 cartons per case. Other configurations may contain additional components such as a foam pad with a pigtail clip. Product Usage: The StatLock PICC Plus and StatLock CV Plus catheter stabilization devices are suture-free stabilization devices for peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) respectively.
Bard Access Systems announces a voluntary field action for the StatLock Catheter Stabilization Devices because some single unit pouches have been released without unique product identifiers (product code, lot number, expiration date, etc.).
- 2017-01-10TerminatedProcess design
StatLock CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per carton and 10 cartons per case. Other configurations may contain additional components such as a foam pad with a pigtail clip. Product Usage: The StatLock PICC Plus and StatLock CV Plus catheter stabilization devices are suture-free stabilization devices for peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) respectively.
Bard Access Systems announces a voluntary field action for the StatLock Catheter Stabilization Devices because some single unit pouches have been released without unique product identifiers (product code, lot number, expiration date, etc.).
- 2013-06-28TerminatedPackaging
StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The StatLock device provides stabilization for compatible medical tubes and catheters.
BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly used during manufacture. The absence of the hydrocolloid strip on the bottom may pose an incremental risk including localized skin irritation. Missing directional arrow may lead to mis-orientation of the StatLock stabilization which may impact the securement of the cathet
- 2007-03-15TerminatedOther
StayFix Fixation Device for Percutaneous catheters, REF 680ME, (small) 5F - 14F, Merit Medical, Unomedical, Ltd., Great Britain.
Sterility of some units may be compromised due to damaged packaging.
- 2007-03-15TerminatedOther
StayFix Fixation Device for Percutaneous catheters, REF 685ME, (large) 12F - 22F, Merit Medical, Unomedical, Ltd., Great Britain.
Sterility of some units may be compromised due to damaged packaging.
- 2007-03-15TerminatedOther
EpiFix Fixation Device for Epidural Catheters, REF 670M, Unomedical, Ltd., Great Britain.
Sterility of some units may be compromised due to damaged packaging.
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