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ShapeIT

IMDS Operations B.V. · Model SI014135 · UDI-DI 08718481740361

DQY Prescription

510(k) clearances

41,793

Adverse events (906 deaths)

620

Recalls

276

Facilities

Description

The ShapeIT is a rapid exchange single lumen guide wire support catheter. The ShapeIT consists of a distal shaft connected to a proximal wire shaft with a proximal end stop on the proximal end and a tip on the distal end of the catheter. On the proximal wire shaft depth markings are applied to indicate that the distal tip of the catheter is at the level of the distal tip of the guiding catheter (95 and 105 cm). Additional distal shaft transition markings are applied to indicate the distal shaft transition is reaching the distal end of the guiding catheter (110 and 120 cm). As aid in positioning the distal tip is radiopaque to make the tip visible with fluoroscopy. The distal part of the shaft is fitted with a hydrophilic coating. The inner lumen of the catheter is coated with MDX coating. The distal two centimeter can be (re)shaped, the distal end has a pre-bend of 180 degrees.

Recalls

Date	Firm	Reason
2026-04-30	MICROVENTION INC.	Due to an increase rate of balloon pinhole defects.
2026-04-21	ARROW INTERNATIONAL, LLC	Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo
2025-09-25	BALT USA, LLC	Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
2025-07-29	Boston Scientific Corporation	Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l
2025-07-29	Boston Scientific Corporation	Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l
2025-07-29	Boston Scientific Corporation	Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l
2025-07-29	Boston Scientific Corporation	Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l
2025-07-29	Boston Scientific Corporation	Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l
2025-07-29	Boston Scientific Corporation	Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l
2025-07-29	Boston Scientific Corporation	Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.