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Optima Coil System recallZ-0660-2022 · Balt USA, LLC · initiated Jan 4, 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 Balt USA, LLC 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

Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mix-up, there is the possibility of inadvertently selecting the incorrect coil size for the procedure potentially causing some harms like vessel damage, an inability to treat with said device and potential rupture of the aneurysm.

FDA root cause category: Process control

What the company is doing

On 01/04/2022, the firm sent an "URGENT FIELD SAFETY NOTICE (FSN)/PRODUCT RECALL" letter via email to customers notifying them of the labeling mix-up which presents a high risk to patient safety and product performance, with the possibility that the user could inadvertently select the wrong size coil for a procedure. Customer/Distributors are instruction to: -Inform their customers about the notice; -Identify and locate the affected products -Collect and put in quarantine the affected products and return them to the Recalling Firm through the Return Material Authorization procedure by contacting the Recalling Firm's Customer Service Department. -Inform the Recalling Firm about the status of every unit of the affected products. -Fulfill the Notice of receipt then return to the Recall Firm via the indicated contact For Hospital Staff: -Within their hospital, inform all Safety Officers, Pharmacists, Head of Neuroradiology and the Neuroradiology Department Staff as well as any other person if deemed necessary. -Identify and locate all affected products and cease or stop using. -Collect and put in quarantine all affected products and return them to their local distributor as per its return procedure; -Inform their local distributor and the Recalling Firm about the status of every unit of affected product. -Contact their local distributor or the Recalling Firm for any additional informaiton. For questions or assistance, contact Quality Department at: email [email protected] address: 29 Parker Suite 100, Irvine CA 92618, USA Telephone number: 949-788-1443 or Fax 949-788-1444

Recall details

Recall number
Z-0660-2022
Status
Open, Classified
Initiated by the company
Jan 4, 2022
Recalling firm
Balt USA, LLC
Quantity
51 devices
Product code
HCG
FDA submissions
K200030
Distribution
Worldwide distribution - U.S. Nationwide distribution in the states of FL and MD. The countries of Denmark, France, Germany, Lebanon, Netherlands, Sweden, Peru, Portugal, Slovenia, Spain, and United Arab Emirates.

Product description

The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a radiopaque distal positioning marker and proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. it is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single-patient-use device which should not to be reused, re-sterilized, opened or tampered with. The Optima Coil System and XCEL Detachment Controller(s) are sold separately. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller.

Code information (models, lots, serial numbers)

Model/REF: OPTI0204CSF10 Lot Number: F210500134 UDI Code: 00818053026010 Model/REF: OPTI0407CSF10 Lot Number: F210500135 UDI Code: 00818053026096

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

139 devices cleared under K200030 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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