Angiodynamics, Inc. recalls SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702
Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)
Read the official notice →- Date
- 2024-08-07
- Country
- United States
- Brand
- Angiodynamics
- Product
- SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702
- Classification
- Class II
- Units
- US Nationwide distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Angiodynamics recalls
- 2026-04-29
USAngiodynamics, Inc. recalls Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145…
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
FDA · DeviceAngiodynamics, Inc.Worldwide distribution - US Nationwide and the countries of Austria,…Official notice →- 2025-03-26
- US
Angiodynamics, Inc. recalls IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Product is mislabeled with the incorrect fill volume.
FDA · DeviceAngiodynamics, Inc.US Nationwide distribution in the states of AZ, DC, FL, TN, TX, VA, WI.Official notice → - 2025-01-08
- US
Angiodynamics, Inc. recalls AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode.
FDA · DeviceAngiodynamics, Inc.US Nationwide distribution to the states of AR, AZ, CA, CO, CT, FL, GA, IL,…Official notice → - 2024-07-10
- US
Angiodynamics, Inc. recalls IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill…
FDA · DeviceAngiodynamics, Inc.US Nationwide distribution in the states of AZ, FL, IL, MO, MS, NJ, NM, NY,…Official notice → - 2024-05-15
- US
- US
Angiodynamics, Inc. recalls DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product…
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Other drugs & medical recalls in the United States
- 2024-08-07
- US
Medivance Inc. recalls Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun…
If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air…
FDA · DeviceMedivance Inc.Worldwide - US Nationwide distribution including in the states of IN, OK, MO,…Official notice → - US
BioFire Diagnostics, LLC recalls BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture…
If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from…
FDA · DeviceBioFire Diagnostics, LLCWorldwide - US Nationwide distribution including in the states of FL, IL, KY,…Official notice → - US
Beckman Coulter Mishima K.K. recalls DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in…
There are two software bug issues with the analyzer. Issue 1: When a dedicated rack is reserved for calibration, after a calibration test has been placed and completed, the same rack may be used to place both a patient…
FDA · DeviceBeckman Coulter Mishima K.K.Worldwide - U.S. Nationwide distribution in the states of AL, CA, GA, HI, IL,…Official notice → - US
Boston Scientific Corporation recalls Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIM Suture…
Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.
FDA · DeviceBoston Scientific CorporationDomestic: Nationwide Distribution. International: PendingOfficial notice → - US
Zimmer, Inc. recalls CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00811400010…
Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF.
- US
EVIDENT SCIENTIFIC INC recalls SlideView VS200 slide viewer,
A broken fuse inside the laser that was caused by a short circuit at PIN 4 of the DOOR CTRL. This short circuit was caused by a badly positioned cable that made contact with the housing/frame and caused a short circuit…