Recall Z-0340-2023— Intuitive Surgical, Inc.

Name: FDA recall Z-0340-2023
Creator: U.S. Food and Drug Administration
Published: 2022-10-07

Class II · Ongoing

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2022-10-07. It names one FDA 510(k) clearance: K211997. Product: INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X REF 48230W INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Blue 4-Row 3.5 mm Xi|X REF 48230B. Reason: Potential staple deployment failure and device fragment generation.

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-10-07
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K211997 — 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 ReloadsIntuitive Surgical, Inc.·cleared 2021-12-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X REF 48230W INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Blue 4-Row 3.5 mm Xi|X REF 48230B

Reason for recall

Potential staple deployment failure and device fragment generation

Data sourced from openFDA. This site is unofficial and independent of the FDA.