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.
Read the official notice →- Date
- 2026-07-29
- Country
- United States
- Brand
- Micro Therapeutics
- Product
- Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter
- Classification
- Class II
- Units
- US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 →- 2025-03-12
- US
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…
FDA · DeviceMicro Therapeutics, Inc.Worldwide distribution: US (nationwide): PR, OK, CA, MD, FL, NY, WA, MI, AL,…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
- 2026-07-29
- US
Emano Metrics, Inc. recalls Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic uroflowmetry system.…
Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while the model was trained and validated on 44,100 Hz audio. The models…
FDA · DeviceEmano Metrics, Inc.U.S. Nationwide distribution in the states of AR, AZ, CA, CO, FL. IA, ID, NC,…Official notice → - US
Olympus Corporation of the Americas recalls Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
KENT IMAGING, INC. recalls SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.
The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shipping mode." When this occurs, an affected…
FDA · DeviceKENT IMAGING, INC.US Nationwide distribution in the states of PA, IA, FL, TX, GA, NV, CA, UT,…Official notice → - US
AVID Medical, Inc. recalls Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.
FDA · DeviceAVID Medical, Inc.U.S. Nationwide distribution in the state of California.Official notice → - US
Boston Scientific Corporation recalls Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose…
FDA · DeviceBoston Scientific CorporationUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL,…Official notice → - US
Penumbra, Inc. recalls Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Due to manufacturing issues, reperfusion catheters may fractures
FDA · DevicePenumbra, Inc.Worldwide - US Nationwide distribution including in the states and territories…Official notice →