Micro Therapeutics, Inc. recalls Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20,…
Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and…
Read the official notice →- Date
- 2025-03-12
- Country
- United States
- Brand
- Micro Therapeutics
- Product
- Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20,…
- Classification
- Class I
- Units
- Worldwide distribution: US (nationwide): PR, OK, CA, MD, FL, NY, WA, MI, 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Micro Therapeutics recalls
- 2026-10-07
USMicro Therapeutics, Inc. recalls Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he Pipeline Flex Embolization…
Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but unit is packaging was a 2.50 mm in diameter.
FDA · DeviceMicro Therapeutics, Inc.U.S. Nationwide distribution in the states of GA and TX.Official notice →- 2026-07-29
- US
Micro Therapeutics, Inc. recalls Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter
Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.
FDA · DeviceMicro Therapeutics, Inc.US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY,…Official notice → - 2024-03-13
- US
Micro Therapeutics, Inc. recalls The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the…
European version of microcatheter were distributed within US which contain a different "Indications for Use".
FDA · DeviceMicro Therapeutics, Inc.US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, HI, IA,…Official notice → - 2022-08-24
- US
Micro Therapeutics, Inc. recalls Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
Outer carton packaging of microcatheters were exposed to wet substance during transport.
- 2022-06-22
- US
Micro Therapeutics, Inc. recalls AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Due to incorrect size and configuration labeling of the detachable coil system.
FDA · DeviceMicro Therapeutics, Inc.International distribution in the countries of China and Republic of Korea.Official notice →
Other drugs & medical recalls in the United States
- 2025-03-12
- US
HUMAN MED AG recalls human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spray jet.
- US
Medimaps Group recalls Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2,…
Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.
FDA · DeviceMedimaps GroupDomestic: AL, AZ, CA, CO, DE, FL, IL, LA, MA, MD, MI, MN, MO, MS, NC, NM, NY,…Official notice → - US
Beckman Coulter, Inc. recalls Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal…
Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared to alternate reagent lots. Patient samples tested with the affected lot may demonstrate repeatable falsely decreased…
FDA · DeviceBeckman Coulter, Inc.Domestic distribution to AL AR AZ CA CT FL ID IL IN KS MA MI NC NE NJ NY OH OR…Official notice → - US
Bard Peripheral Vascular Inc recalls Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F…
Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could…
FDA · DeviceBard Peripheral Vascular IncUS Nationwide Distribution: NY, VA, KY, IN, OR, FL, MD, NJ, LA, CO, PR, PA,…Official notice → - US
Biosense Webster, Inc. recalls VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac…
Due to an observed trend of neurovascular events
FDA · DeviceBiosense Webster, Inc.Worldwide distribution; US states of AR, CA, CO, KS, LA, MA, MO, NY, OH and…Official notice → - US
Zydus Pharmaceuticals (USA) Inc recalls Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose…
Failed Impurities/Degradation Specifications