—#171014

Product

Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.

FDA product code: DRC — Trocar
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Lot 8833687

Why it was recalled

The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion.

Root cause (FDA determination)

Process control

Action the firm took

Urgent Medical Device Recall notification letters were sent to customers on 2/1/19. Action to take 1. Examine your inventory immediately to determine if you have affected product(s), and quarantine affected product(s). Immediately cease all distribution and use of these products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. NOTE: Unaffected products that are returned will not be credited. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return it via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. 5. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time) or by email to CustomerRelationsNA@CookMedical.com.

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: US nationwide and Canada. US distribution to the following states: AZ, FL, IL, IN, KS, MA, MI, MO, PA, SC, TN, and WA. The products were distributed to the following foreign countries: Canada.

Timeline

Recall initiated: 2019-02-01
Posted by FDA: 2019-03-13
Terminated: 2020-06-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.