FDA Medical Device Recalls (openFDA)
Micro Therapeutics, Inc.: Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only
- Recall number
- Z-1557-2022
- Recalling firm
- Micro Therapeutics, Inc.
- Product
- Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only
- Status
- Open, Classified
- Initiated
- 2022-06-30
- Posted
- not on file
- Terminated
- not on file
- Reason
- Outer carton packaging of microcatheters were exposed to wet substance during transport.
- Root cause
- Under Investigation by firm
- Action
- On June 30, 2022, Micro Therapeutics, Inc. issued a "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" to affected customers. The recall notification ask consignees to take the following actions: 1. Do NOT use any impacted product. Remove and quarantine all unused impacted product in your inventory. 2. Return the impacted products to Medtronic. Your Medtronic representative may assist in facilitating the return of product, as necessary. If alternative product is needed, your Medtronic representative can assist you with identifying a suitable replacement product. 3. Complete and return the Customer Confirmation Form enclosed in this letter acknowledging that you have received this information. 4. This communication needs to be passed to all those who need to be aware within your organization where impacted devices have been transferred, and to any other associated organizations that may be impacted by this action. 5. Adverse reactions or quality problems experienced with this product should be reported to Medtronic and FDA MedWatch Adverse Event Reporting program via: " Medtronic Quality Assurance at rs.nvcomplaints@medtronic.com or call +1 (763) 514-4000 (Worldwide) " The FDA website (http://www.fda.gov/Safety/MedWatch/HowtoReport/default.htm) or call FDA at 1-800-FDA-1088.
- Quantity
- 2 units
- Distribution
- US Nationwide Distribution: None OUS: Brazil
- Lot, serial or model codes
- Lot # B262322 UDI: (00) 847536005983
- 510(k) numbers
- ["K030688","K093750"]
- PMA numbers
- not on file
- Product code
- KRA
- Firm FEI
- 3004904811
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28