Bard Peripheral Vascular Inc recalls The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent…
An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.
Read the official notice →- Date
- 2023-02-15
- Country
- United States
- Brand
- Bard Peripheral Vascular
- Product
- The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework.…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution including in the states of AK, AL,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Bard Peripheral Vascular recalls
- 2023-10-11
USBard Peripheral Vascular Inc recalls Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohibits the biopsy needle (cutting cannula) from properly…
FDA · DeviceBard Peripheral Vascular IncWorldwide - US Nationwide distribution in the states of PR, CO, TX, CA, WA,…Official notice →- 2023-05-17
- US
Bard Peripheral Vascular Inc recalls Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM
Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the biopsy needle from properly fitting into the coaxial cannula and…
FDA · DeviceBard Peripheral Vascular IncUS Nationwide Distribution: PR, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA,…Official notice → - 2023-03-22
- US
Bard Peripheral Vascular Inc recalls Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK
The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirement of an additional device, 3), Needle tip breakage, if…
FDA · DeviceBard Peripheral Vascular IncWorldwide Distribution: US (Nationwide) includes states of: FL, MD, OH, CO,…Official notice → - 2023-02-08
- US
Bard Peripheral Vascular Inc recalls Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter Repair Kit…
Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).
FDA · DeviceBard Peripheral Vascular IncWorldwide Distribution: U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE,…Official notice → - 2022-06-29
- US
Bard Peripheral Vascular Inc recalls REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,
There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods: Universal extension set and drainage bag,…
FDA · DeviceBard Peripheral Vascular IncWorldwide distribution - US Nationwide distribution in the states of MS, NC,…Official notice → - 2022-03-23
- US
Bard Peripheral Vascular Inc recalls LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
FDA · DeviceBard Peripheral Vascular IncU.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA,…Official notice →
Other drugs & medical recalls in the United States
- 2023-02-22
- US
HTO Nevada, Inc. recalls Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL SOURCE, Portland, OR,…
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
- US
Amerisource Health Services LLC recalls Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-count…
Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.
- US
McGuff Compounding Pharmacy Services, Inc. recalls Thiamine Hydrochloride 200 mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW…
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
- 2023-02-15
- US
Trackx Technology Inc recalls TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model…
The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.
FDA · DeviceTrackx Technology IncUS Nationwide distribution in the states of AZ, FL, LA, NC, PA, VA, WA, WI.Official notice → - US
Roche Molecular Systems, Inc. recalls cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number…
The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress,…
FDA · DeviceRoche Molecular Systems, Inc.Domestic distribution nationwide. Foreign distribution worldwide.Official notice → - US
Olympus Corporation of the Americas recalls SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an incorrect DVI cable supplied may result in prolonged…
FDA · DeviceOlympus Corporation of the AmericasFL, GA, IN, MD, MS, NY, OH, PA, RI, SC, VAOfficial notice →