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EchelonTM recallZ-1557-2022 · Micro Therapeutics, Inc. · initiated Jun 30, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Micro Therapeutics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Outer carton packaging of microcatheters were exposed to wet substance during transport.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-1557-2022
Status
Open, Classified
Initiated by the company
Jun 30, 2022
Recalling firm
Micro Therapeutics, Inc.
Quantity
2 units
Product code
KRA
FDA submissions
K093750, K030688
Distribution
US Nationwide Distribution: None OUS: Brazil

Product description

Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only

Code information (models, lots, serial numbers)

Lot # B262322 UDI: (00) 847536005983

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

15 devices cleared under K093750, K030688 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 90622).

Sources and updates

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