Z-1556-2022Class II

Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only

Name: Z-1556-2022 Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
Creator: Micro Therapeutics, Inc.
Published: 2022-06-30
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2022-06-30 / Open, Classified / root cause: packaging

FDA source

Micro Therapeutics, Inc. began a recall of Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only on 2022-06-30. FDA classified it as Class II and gives the reason as "Outer carton packaging of microcatheters were exposed to wet substance during transport". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1556-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-30
Posted: 2022-08-18
Recalling firm: Medtronic, Inc.
Product: Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
Product code: KRA Catheter, Continuous Flush
Reason for recall: Outer carton packaging of microcatheters were exposed to wet substance during transport.
Root cause tag: packaging
FDA 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 [email protected] 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 in commerce: 8 units
Distribution: US Nationwide Distribution: None OUS: Brazil
Product codes and lots: Lot # B177543 UDI: (00) 847536006270

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1556-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1556-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-24	2022-08-18
Z-1557-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-24	2022-08-18

Product code KRA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)