ACCESSRAIL Platform (Standard Blade) Part Number SB-1000… recallZ-2271-2023 · Maquet Cardiovascular, LLC · initiated Jun 28, 2023

Why it was recalled

The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.

FDA root cause category: Nonconforming Material/Component

What the company is doing

An URGENT MEDICAL DEVICE Removal notification dated 6/28/23 was sent to customers. Actions to be taken by the customer: Our records indicate that you have received the ACCESSRAIL Platform (Standard Blade), ACCESSRAIL Platform (Deep Blades), ACROBAT SUV Vacuum Off-Pump System, ACROBAT V Vacuum Off-Pump System, or ACROBAT-i Vacuum Stabilizer System having one or more of the lot numbers that are affected by this recall. " Please examine your inventory immediately to determine if you have any of the ACCESSRAIL Platform (Standard Blades), ACCESSRAIL Platform (Deep Blades), ACROBAT SUV Vacuum Off-Pump System, ACROBAT V Vacuum Off-Pump System, or ACROBAT-i Vacuum Stabilizer System with the product codes/lot numbers listed in this notice. " If you have unused/unexpired affected product that you will be returning from your inventory, please contact Maquet/Getinge Customer Service at 888- 9GETUSA (888-943 8872) (option 2) between the hours of 8 AM and 6 PM Eastern Standard Time to request a return authorization number (RMA) and shipping instructions. o If you have affected product, you are entitled to a credit. You will receive credit upon your acknowledgement that you have affected product for return. o No new product is expected to exhibit this issue. " Please complete and sign the attached MEDICAL DEVICE Removal - RESPONSE FORM (pages 5 & 6) to acknowledge that you have received this notification. " Return the completed form to Maquet/Getinge by e-mailing a scanned copy to [email protected] or by faxing the form to +1(877) 589-3171. " Please forward this information to all current and potential ACCESSRAIL Platform (Standard Blades), ACCESSRAIL Platform (Deep Blades), ACROBAT SUV Vacuum Off-Pump System, ACROBAT V Vacuum Off-Pump System, or ACROBAT-i Vacuum Stabilizer System users within your hospital / facility. " If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate actio

Recall details

Recall number

Z-2271-2023

Status

Open, Classified

Initiated by the company

Jun 28, 2023

Posted by the FDA

Jul 31, 2023

Recalling firm

Maquet Cardiovascular, LLC

Quantity

785 units

Product code

DWS

Distribution

Worldwide distribution - US Nationwide and the countries of Bangladesh, Brazil, Chile, Colombia, Iran, Jordan, Malaysia, Mexico, Netherlands, Singapore, Sudan, Taiwan, Thailand, and United Arab Emirates.

Product description

ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and chest surgery.

Devices named in this recall

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

• ACCESSRAIL Platform (Standard Blade) SB-1000

  Maquet Cardiovascular LLC · Instruments, Surgical, Cardiovascular
  1 recall6 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 92446).

• Z-2272-2023 · Open, Classified
  ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
• Z-2273-2023 · Open, Classified
  ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.
• Z-2274-2023 · Open, Classified
  ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.